Robot-assisted IVOR-LEWIS Esophagectomy
Raktažodžiai
Santrauka
apibūdinimas
This confirmatory, nonrandomized, single-arm trial (phase II) will be conducted to evaluate short-and long-term outcomes of robot-assisted thoraco- laparoscopic minimally invasive esophagectomy for esophageal cancer. Patients will registered preoperatively. The planned sample size was 51. Preoperative endoscopic biopsy was performed in all patients to confirm the histological diagnosis of esophageal cancer. Staging workup included thorough history and physical examination, esophagogastroduodenoscopy, endoscopic ultrasonography, and integrated positron emission tomography/computed tomography scan. Patients with histologically proven malignancy were candidates for surgical procedures. Operability criteria were defined according to the National Comprehensive Cancer Network guidelines. All patients were within the American Society of Anesthesiologists (ASA) class I to III. In general, neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease. The primary endpoint in the first stage is the short-term postoperative complications, and that in the second stage is overall survival; patients continue to be followed up for this endpoint.
Datos
Paskutinį kartą patikrinta: | 06/30/2019 |
Pirmasis pateikimas: | 05/01/2017 |
Numatytas registravimas pateiktas: | 05/01/2017 |
Pirmas paskelbtas: | 05/03/2017 |
Paskutinis atnaujinimas pateiktas: | 07/10/2019 |
Paskutinis atnaujinimas paskelbtas: | 07/11/2019 |
Faktinė studijų pradžios data: | 06/13/2017 |
Numatoma pirminio užbaigimo data: | 07/09/2019 |
Numatoma studijų užbaigimo data: | 04/03/2024 |
Būklė ar liga
Fazė
Tinkamumo kriterijai
Amžius, tinkami studijuoti | 18 Years Į 18 Years |
Tinkamos studijoms lytys | All |
Mėginių ėmimo metodas | Probability Sample |
Priima sveikus savanorius | Taip |
Kriterijai | Inclusion Criteria: 1. Patients with histologically proven esophageal malignancy 2. All patients were within the American Society of Anesthesiologists (ASA) class I to III 3. neoadjuvant chemoradiotherapy was offered to patients with T2-3 or N1-2 disease Exclusion Criteria: Cancer located at the cervical esophageal Cancer located at the gastroesophageal junction history of surgery in the right thorax |
Rezultatas
Pirminės rezultatų priemonės
1. short-term postoperative complications [30 days after surgery]
2. long-term overall survival [five years after surgery]
Antrinės rezultatų priemonės
1. perioperative outcomes except for postoperative complications [30 days after surgery]